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510(k) Data Aggregation

    K Number
    K113585
    Device Name
    NASAL/EPISTAXIS PACK
    Manufacturer
    COGENT THERAPEUTICS, LLC
    Date Cleared
    2012-04-25

    (142 days)

    Product Code
    LYA, EMX
    Regulation Number
    874.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    COGENT THERAPEUTICS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nasal/Epistaxis Pack is a sterile, single use device intended for use in patients undergoing nasal/sinus surgery as a space-occupying packing. The Nasal/Epistaxis Pack is indicated for use in patients undergoing nasal/sinus surgery as a space occupying packing to: Separate tissue or structures compromised by surgical trauma; Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; Help control minimal bleeding following surgery or trauma; Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; Act as an adjunct to aid in the natural healing process. The Nasal/Epistaxis Pack is indicated for use as a nasal packing to treat epistaxis.
    Device Description
    The Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol (PEG) and chitosan provided as a dry 4.0 cm x 2.4 cm x 0.3 cm pack. Upon placement, the Nasal/Epistaxis Pack absorbs fluids in the field and swells and conforms to the mucosal tissue/treatment site surfaces to separate tissues and prevent adhesions, control minimal bleeding following surgery or trauma, to treat epistaxis, and to act as an adjunct to aid in the natural healing process.
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